JP2003040795A - Antihyperlipidaemic composition and method for manufacturing the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an antihyperlipidaemic composition having excellent hypocholesterolemic activity. SOLUTION: The antihyperlipidaemic composition contains one or more kinds of basidiomycetes belonging to Polyporaceae of Basidiomycetes and a root of a plant belonging to Araliaceae as active ingredients. The composition exhibits excellent hypocholesterolemic activity.

Description

Detailed Description of the Invention

[0001]

TECHNICAL FIELD The present invention relates to a composition having an antihyperlipidemic activity and capable of being used as a drug for treating or preventing hypercholesterolemia, and particularly to a composition such as total cholesterol and / or LDL cholesterol. It relates to a composition having a lowering action. The present invention also relates to a composition effective as a drug for treating or preventing diabetes at the same time, and particularly to a composition effective as a drug for treating or preventing hyperlipidemia in a diabetic patient.

[0002]

2. Description of the Related Art Conventionally, the fruiting body of Ganoderma lucidum belonging to the family Basidiomycetes, Rhododendronaceae, and the extracted components thereof, mycelium cultures (in addition to mycelia, culture solutions are also referred to simply as cultures). It has been known for a long time as a crude drug, and it is known that it has a variety of medicinal properties, and also has a certain antitumor activity in low-molecular components such as polysaccharides contained therein. Similarly, various physiologically active substances including antitumor activity are also extracted from fruiting bodies of Pleurotus cornucopiae belonging to the family Basidiomycetes Asteraceae.

Furthermore, the roots of plants belonging to the family Araliaceae such as medicinal carrots and their extracted components have been used as crude drugs for a long time, and many of them are known to have medicinal effects. The roots of plants belonging to the family Araliaceae such as carrots and their extracted components have also been used as crude drugs for a long time. It should be noted that the cholesterol-lowering effect of Chixetuni ginseng, particularly the LDL cholesterol-lowering effect, has not yet been known.

[0004] In general, various therapies including the treatment and prophylaxis performed by administering a crude drug have the merit that side effects are small, but the effects may not be remarkable in some cases. It is empirically and experimentally known that the basidiomycete extract component and the carrot extract component each have excellent medicinal effects, but by combining these specific components and combining these components, the It was not known that the activity was synergistically improved.

On the other hand, various known therapeutic agents are known for hyperlipidemia in which blood cholesterol level is high. HMG-CoA reductase inhibitor preparations such as pravastatin and simvastatin, clofibrate preparations such as clinofibrate and besafibrate, nicotinic acid preparations such as niceritrol and uperanicotinate, cholestyramine which is an anion exchange resin, and enzyme preparations. There are certain elastase, dextran preparations, linoleic acid preparations, EPA preparations and the like.

[0006]

However, although these therapeutic agents are excellent in the effect of lowering total cholesterol, they all have side effects. Therefore, an object of the present invention is to provide an antihyperlipidemic composition having a preferable cholesterol lowering effect. Another object of the present invention is to provide an antihyperlipidemic composition that has no side effects or is sufficiently reduced. Another object of the present invention is to provide a composition for preventing or treating diabetes which is excellent in blood glucose lowering action. Another object is to provide a composition for preventing or treating antihyperlipidemia in diabetic patients.

[0007]

Means for Solving the Problems The present inventor has been studying the pharmacological action of basidiomycete fruiting bodies and roots of Araliaceae plants for many years. When combined with roots,
The inventors have found that it effectively acts on the reduction of blood cholesterol and completed the present invention. The present inventor has also found that at the same time, this composition lowers the blood glucose level of diabetic patients, and completed the present invention. That is, the above-mentioned problem is solved by the following means.

(1) Basidiomycetes An antihyperlipidemic composition containing, as an active ingredient, at least one kind of basidiomycete belonging to the family Sarcophaga family and roots of plants belonging to the family Araliaceae. (2) The composition according to claim 1, wherein the one or more kinds of basidiomycetes is Ganoderma lucidum and / or Kawaratake. (3) The plant of the family Araliaceae is 1 or 2 or more species selected from the group consisting of Panax ginseng, Chixetsu ginseng, and Densin ginseng.
The composition as described. (4) The composition according to any one of claims 1 to 3, which has a raw material composition of 15 to 20 parts by weight of the roots of Araliaceae plants with respect to 100 parts by weight of the basidiomycete. (5) The composition according to any one of claims 1 to 4, wherein the basidiomycetes are two types, Ganoderma lucidum and Pleurotus cornucopiae, and the Araliaceae plant is Chixetuni ginseng. (6) Ganoderma lucidum 9-11 parts by weight, Kawaratake 4.5
The composition according to claim 5, which has a raw material composition of about 5.5 parts by weight to 2.7 to 3.3 parts by weight of ginseng carrot. (7) The composition according to any one of claims 1 to 6, which also has a blood glucose lowering action. (8) A composition for treating or preventing diabetes, which comprises, as an active ingredient, at least one kind of basidiomycete belonging to the family Sarcophaga family and roots of a plant belonging to the family Araliaceae. (9) An anti-hyperlipidemic composition for diabetic patients, which comprises, as active ingredients, one or more kinds of basidiomycetes belonging to the family Basidiomycetes, and roots of plants belonging to the family Araliaceae.

[0009]

BEST MODE FOR CARRYING OUT THE INVENTION Embodiments of the present invention will be described in detail below. Ganoderma lucidum, Pleurotus cornucopiae, and the like belong to the family Basidiomycetes, Pleurotus chinensis. In the present invention, the fruiting bodies and / or mycelium cultures (including mycelia and culture medium) of one or more kinds of fungi belonging to these Sarcophagous family, or an extract component obtained from any of these Is contained as an active ingredient.

(Active ingredient derived from Basidiomycetes) As the basidiomycete, preferably one or more kinds selected from Ganoderma lucidum and Pleurotus cornucopiae are used. Particularly preferably, Ganoderma lucidum and Kawaratake are used together. In the present specification, the taxonomic identification of basidiomycetes used is
It is based on "Primary-color Japanese fungus pictorial book" (nursery company) co-authored by Rokuya Imaseki and Tsugio Hongo.

Especially for Ganoderma lucidum, Reishi F
Ungus (Ganoderma Lucidum) can be illustrated.
Although this fungus naturally prefers to propagate on trees, it is rare for native fungi. Note that artificial cultivation is also possible. This bacterium has a glossy, wax-like bulky portion and a shaft portion, and the length of the shaft can reach about 15 cm. The fruit body color is red, blue, yellow, white, purple, or black. This fungus grows on stumps and near the base of trees that are weakened by disease, forming white filaments.

[0012] Coriolus Ver.
sicolor can be illustrated. This fungus grows naturally in western Japan, especially in the Shinshu region (especially Nagano prefecture), the Shikoku region, and the Kyushu region. This fungus is naturally a euphilia,
I especially like hardwood. The basidiomycetes may be naturally occurring, artificially cultivated, or cell cultivated, and are not particularly limited. Preferably, it is naturally occurring.

The form of these fungi used in the present invention may be fruit bodies and / or cell cultures,
Preferred is a fruiting body. Especially for Ganoderma lucidum, it is preferable to use black fruiting bodies that are naturally matured. Moreover, as for Pleurotus cornucopiae, it is preferable that the fruiting body is an autogenous fruiting body collected in summer, and it is more preferable that it is air-dried at room temperature while avoiding light. The fruiting body is preferably air-dried at room temperature while avoiding light. Fruiting bodies are available as dried solids, alcohol immersion liquids, pastes or extracts.

The composition of the present invention may contain basidiomycetes as an active ingredient. Therefore, in the case of a fruiting body raw material, the fruiting body may be contained as it is as a solid active ingredient in the form of powder, flakes or the like. Further, in the case of a culture, it may be contained as a liquid such as a culture solution containing mycelial cells or a solid such as a dried product of mycelial cells.

Further, the composition of the present invention can contain, as an active ingredient, an extract component obtained by extracting a fruiting body of basidiomycete or a culture thereof with water and / or alcohol.

(Preparation Method of Extraction Component of Basidiomycetes) At the time of extraction, it is preferable to pulverize the fruiting body of basidiomycete into a powder or a strip. More preferably, it is in the form of fragments of about 5 mm square or less, and further preferably 0.5 mm to 2 m.
It is a m-square strip. When the mycelial cells are used as a raw material, it is preferable to use a dried powder.

When extracting with water, the water used is not particularly limited, but it is preferable to heat during extraction. The temperature is preferably 80 to 100 ° C., and more preferably 9
It is 0 to 95 ° C. Although the extraction time is not particularly limited, it is preferably 1 hour or less, more preferably 30 minutes or more and 60 minutes or less. Further, the amount of water with respect to the extraction raw material is not particularly limited, but the raw materials 5 to 2
It is preferable to make 800 ml of water to 5 g (more preferably 10 to 20 g, most preferably about 15 g). The extraction operation is carried out in an open-air container, in particular made of glass,
In addition to enamel and ceramics, it is preferable to use a material in which a metal portion is coated or processed with a corrosion resistant coating. It is also preferably carried out using a reflux condenser. The heat extraction operation is not particularly limited, but in the case of the above-mentioned amount of the raw material to the extraction liquid, the extraction liquid is about 60%. When the amount of water with respect to the extraction raw material is 800 ml, the extraction liquid amount is preferably about 500 ml. This extract has a concentration suitable for oral administration as it is.

The following operation can be mentioned as a typical example of extracting the basidiomycete raw material with water. To 15 g of dried basidiomycete raw material (preferably fruiting bodies, preferably in the form of flakes), 800 ml of hot water was added to obtain 90 g.
While maintaining at ~ 95 ° C, brew until the remaining amount of the extract is 500 ml. Preferably, the heating is adjusted so that the amount of the solution becomes 500 ml in about 30 minutes. In particular, it is preferable to use a reflux condenser. The extract obtained by such an operation becomes a liquid having a concentration suitable for oral administration as it is.

In the case of extraction with alcohol, it is preferable that the alcohol used is a drinkable alcohol, considering that it may be drunk as it is. That is, it is preferable to use ethanol. When extraction is performed using alcohol, extraction may be performed only with alcohol, but it is preferable to perform extraction with a mixed solution by mixing with water. Preferably, the alcohol concentration is 50 v / v%
It is below, and more preferably about 35 v / v%. The alcohol-containing extract is not particularly limited, but it is preferable to heat it during extraction. The temperature is preferably 50 to 80 ° C., more preferably 75 ° C. or lower, and further preferably 70 ° C. or lower. Although the extraction time is not particularly limited, it is preferably 10 hours or longer, more preferably 20 hours or longer, and most preferably about 30 hours or longer. The alcohol concentration is preferably about 20 v / v% at the final oral administration. Therefore, when extraction is performed with an alcohol solution having a concentration exceeding 20 v / v%, it is preferable to dilute with water after the extraction so that the concentration becomes 20 v / v%. Further, the amount of the extraction liquid with respect to the extraction raw material is not particularly limited, but about 50
˜250 g, more preferably 100 to 200 g, and even more preferably about 150 g, and 1000 ml of the extract is preferred. The extract obtained by such an operation is
As it is, it becomes a liquid having a concentration suitable for oral administration. It is preferable to use the same container for extraction as in the case of extracting with water only. The extraction operation is preferably carried out using a reflux condenser.

When alcohol is used for extraction, components that cannot be extracted by water alone are extracted. The ethanol-containing extract of basidiomycetes contains triterpenoids,
Nucleosides (adenosine, guanosine) and polysaccharides include hetero-β-glucan, xylo-β-glucan and manno-β-glucan.

The following operation can be mentioned as a typical example of extraction of a basidiomycete raw material with a water / alcohol mixture. 35 v / v% in 150 g of basidiomycete raw material (preferably fruiting bodies, preferably in the form of pieces) crushed into pieces
An ethanol solution is added to make 1000 ml, and this solution is maintained at about 70 ° C. and decocted for about 30 hours. After 30 hours,
Hot water (or water) is added so that the total amount becomes 1000 ml. In addition, it is preferable that the alcohol concentration finally becomes about 20 v / v%.

The various extracts thus obtained are filtered or the like, if necessary. The extract may be used as it is as an active ingredient. In addition, if necessary, the product may be concentrated and concentrated to obtain the active ingredient. Further, by evaporating the water content, an extraction component as a solid content is also obtained, and further, if necessary, drying or the like is performed to obtain a desired dry extraction component. When two or more types of basidiomycetes are used, the extracted components can be individually extracted or two or more types can be simultaneously extracted. Furthermore, in consideration of the dosage form and dosage form of the present composition, an additive for stabilizing the extract or the extract may be added when the extract is concentrated or dried.

(Active ingredient derived from roots of Araliaceae) The composition of the present invention also contains the root or extract of Araliaceae as an active ingredient. As a medicinal carrot of the Araliaceae plant, rapeseed ginseng (Panax ginseng C.
A. Meyer) and American ginseng (P. quinquefolium
L.), Radix Notoginseng (Panaeo Radix ginseng, P. notogingseng), Ginseng Takesetsu (Ginseng ginseng) (Tamushi, P. japonicus C.
A.Meyer) etc. are included. In the present invention, one kind or two or more kinds of them can be used in combination, and the roots of plants selected from Chixetunidin ginseng and its related species (hereinafter referred to as roots of Chixetunin ginseng and the like). Is preferably used. Most preferred is Chixetun ginseng. The roots of these carrots, including the roots of Chixetuni ginseng and its related plants, are usually available in a dried state. Alternatively, it can be obtained as an alcohol immersion liquid, a paste, or an extract.

The roots of Araliaceae plants may be so-called plant roots, or may be cultured cells.
In the case of cultured cells, root-derived cultured cells are preferred. In addition, as long as the raw material derived from the root of the plant is contained, a raw material containing a site other than the root of the plant can also be used.

The composition of the present invention may contain roots of Araliaceae plants as active ingredients. Therefore, in the case of a plant raw material, the roots of Araliaceae plants may be contained as they are as solid active ingredients such as powder and flakes. When derived from cultured cells, it may be contained as a liquid such as a culture solution containing the cultured cells or a solid such as a dried cell product.

(Method for preparing root extract component of Araliaceae plant)
Further, the composition of the present invention can contain, as an active ingredient, an extract component obtained by extracting the roots of Araliaceae plants with water and / or alcohol.
When extracting, crush the carrot root of the plant, etc.
It is preferable to make it into a powder form or a strip form. More preferably,
It is a fragment of about 5 mm square or less, and more preferably,
It has a strip shape of 0.5 mm to 2 mm square. When cultured cells are used as a raw material, it is preferable to use a dried powder.

When extracting with water, the water used is not particularly limited, but it is preferable to heat during extraction. The temperature is preferably 80 to 100 ° C., and more preferably 9
It is 0 to 95 ° C. Although the extraction time is not particularly limited, it is preferably 1 hour or less, more preferably 30 minutes or more and 60 minutes or less. Also, the amount of water for the extraction raw material is not particularly limited, but the raw materials 1 to 8
It is preferable that the amount of water is 800 ml per g, preferably 2 to 6 g, and more preferably about 3 g. The extraction operation is
It is preferable to use a container open to the atmosphere, particularly made of glass, enamel, or ceramics, or a material in which a metal portion is coated or processed with a corrosion resistant coating. It is also preferably carried out using a reflux condenser. The heat extraction operation is not particularly limited, but in the case of the above-mentioned amount of the raw material to the extraction liquid, the extraction liquid is about 60%. That is, when the amount of water with respect to the extraction raw material is 800 ml, the amount of the extraction liquid is preferably about 500 ml. This extract has a concentration suitable for oral administration as it is.

The following operation can be mentioned as a typical example of extracting the roots of Araliaceae plants, which are plants, with water. For 3 g of dried root of carrot crushed into strips,
800 ml of hot water is added, and brewed so that the remaining amount of the extract is 500 ml in the above heating range. Preferably, while maintaining the temperature of the extract at 90 to 95 ° C., 50 minutes after about 30 minutes.
Adjust the heat so that the amount becomes 0 ml. In particular, a reflux condenser may be used. The extract obtained by such an operation becomes a liquid having a concentration suitable for oral administration as it is.

In the case of extraction with alcohol, the alcohol used is preferably a drinkable alcohol considering that it may be drunk as it is. That is, it is preferable to use ethanol. When extraction is performed using alcohol, extraction may be performed only with alcohol, but it is preferable to perform extraction with a mixed solution by mixing with water. Preferably, the alcohol concentration is 50 v / v%
It is below, and more preferably about 35 v / v%. The alcohol-containing extract is not particularly limited, but it is preferable to heat it during extraction. The temperature is preferably 50 to 80 ° C., more preferably 75 ° C. or lower, and further preferably 70 ° C. or lower. Although the extraction time is not particularly limited, it is preferably 10 hours or longer, more preferably 20 hours or longer, and most preferably about 30 hours or longer. The alcohol concentration is preferably about 20 v / v% at the final oral administration. For example, when extraction is performed with an alcohol solution having a concentration exceeding 20 v / v%, it is preferable to dilute with water after the extraction so that the concentration becomes 20 v / v%. The amount of the extraction liquid for the extraction raw material (carrot root) is also not particularly limited, but it is preferable to use 1000 ml of the extraction liquid for 30 g of the raw material. It is preferable to use the same container for extraction as in the case of extracting with water only. The extraction operation is preferably carried out using a reflux condenser.

The following operation can be mentioned as a typical example of extracting the roots of Araliaceae plants with a water / alcohol mixture. 30 g of dried root of Araliaceae plant crushed into small pieces
35v / v% ethanol solution to 1000ml,
The liquid is maintained at about 70 ° C. and decocted for about 30 hours. After 30 hours, hot water (or water) is added so that the total amount becomes 1000 ml. In addition, it is preferable that the alcohol concentration finally becomes about 20 v / v%. The extract obtained by such an operation becomes a liquid having a concentration suitable for oral administration as it is.

The obtained extract is filtered or the like, if necessary. The extract may be used as it is as an active ingredient. Also,
If necessary, the product may be concentrated and concentrated, and this may be used as an active ingredient. Further, by evaporating the water content, an extraction component as a solid content is also obtained, and further, if necessary, drying or the like is performed to obtain a desired dry extraction component.
The roots of Araliaceae plants can be used not only in one kind but also in two or more kinds. In that case, the extract may be prepared for each kind, or the extract may be used in any combination of two or more kinds. May be prepared. Furthermore, in consideration of the dosage form and dosage form of the present composition, an additive for stabilizing the extract or the extract may be added when the extract is concentrated or dried.

The basidiomycete raw material and the root material of the Araliaceae plant can be extracted individually, or the raw material composition containing both can be extracted with the same extraction medium and extracted simultaneously. Preferably, they are extracted simultaneously. Also in the case of simultaneous extraction, the extraction conditions for the basidiomycete raw material or the root raw material of Araliaceae plants described above can be adopted. It is most preferable to mix the active ingredient obtained by extracting the basidiomycete raw material and the root raw material of the Araliaceae plant with water and the active ingredient obtained by extraction with a water / alcohol (ethanol) mixture to obtain the present composition. In this case, it does not matter whether or not simultaneous extraction is performed, but simultaneous extraction is preferable.

A typical example of simultaneous extraction will be shown below. 5
With respect to 10 g of fruiting bodies of Ganoderma lucidum, 5 g of fruiting bodies of Pleurotus cornucopiae, 3 g of roots of Araliaceae plants (preferably roots of Chixetuni ginseng), which are crushed into strips of less than mm mm, preferably about 0.5 to 2 mm, 800 ml of hot water is added, and brewed so that the remaining amount of the extract is 500 ml in the above heating range. Preferably, the heating is adjusted so that the amount of the solution becomes 500 ml in about 30 minutes. The extract obtained by such an operation (particularly when a reflux condenser is used) has a liquid concentration suitable for oral administration as it is. In addition, a raw material mixture having the same form and composition (however, 100 g of Ganoderma lucidum fruiting body, 50 g of Kawaratake fruiting body, and 30 g of root of Araliaceae plant) were mixed with 35 v / v% ethanol solution to make 1000 ml, and this solution was used. Is maintained at about 70 ° C for about 30
Brew for hours. After 30 hours, hot water (or water) is added so that the total amount becomes 1000 ml. In addition, it is preferable that the alcohol concentration finally becomes about 20 v / v%. The extract obtained by such an operation is a liquid having a concentration suitable for oral administration as it is. These two extracts are
Since each contains all of the active ingredients of the present invention, each can be provided alone as the composition. On the other hand, the two extracts can be mixed in advance to form the present composition as one preparation, or two preparations that are mixed at the time of administration, or both separately but simultaneously administered. It is provided as a planned set of formulations.

The composition of the present invention comprises a basidiomycete extract with water and / or alcohol, a root extract of Araliaceae plant with water and / or alcohol, an active ingredient derived from basidiomycete and an Araliaceae family. It can be appropriately combined so as to include the active ingredient derived from the root of the plant. For example, a water extract component of basidiomycete and an alcohol extract component of roots of Araliaceae plants can be combined.
As described above, in the final administration stage, if the composition contains an active ingredient derived from Basidiomycetes and an active ingredient derived from the roots of Araliaceae plants, only in the case of preparing the composition from only one type of preparation. Alternatively, the present composition can be prepared by combining two or more kinds of preparations.

In the present invention, both the basidiomycete-derived active ingredient and the root-derived active ingredient of Araliaceae plants are contained, but the preferable ratio of the active ingredient corresponds to the weight ratio of the extraction raw material. The mixing ratio of the basidiomycete and the root of the Araliaceae plant is such that the root of the Araliaceae plant is 15 to 2 relative to 100 parts by weight of the basidiomycete.
It is preferably 0 part by weight. More preferably, 2 to 4 parts by weight of roots of Araliaceae plants are used with respect to 15 parts by weight of basidiomycetes. Furthermore, 3 parts by weight of roots of Araliaceae plants are more preferable for 15 parts by weight of basidiomycetes. In these formulations, the basidiomycete preferably contains Ganoderma lucidum and Pleurotus cornucopiae, more preferably only Ganoderma lucidum and Pleurotus cornucopiae. It is preferable that kawatake mushroom is contained in a ratio of 3 to 7 parts by weight with respect to 10 parts by weight of Ganoderma lucidum in the total weight of basidiomycetes. In particular, it is preferable that the ratio is 5 parts by weight of Kawaratake for 10 parts by weight of Ganoderma lucidum.

More preferably, 5 parts by weight of Pleurotus cornucopiae, roots of Araliaceae plant 1.
It is preferably 5 to 6 parts by weight. Moreover, it is more preferable to use 9 to 11 parts by weight of Ganoderma lucidum, 4.5 to 5.5 parts by weight of Ganoderma lucidum, and 2.7 to 3.3 parts by weight of ginseng, and 5 parts by weight of Ganoderma lucidum to 10 parts by weight of Ganoderma lucidum. And more preferably 3 parts by weight of the roots of Araliaceae plants. Also, Ganoderma lucidum 4.5
~ 5.5 parts by weight, Kawaratake 9-11 parts by weight,
It is also preferable to use 2.7 to 3.3 parts by weight of the roots of Araliaceae plants.

On the other hand, it is also a preferable combination that 0.5 part by weight to 2 parts by weight of roots of Araliaceae plants are used with respect to 2 parts by weight of basidiomycete. It is more preferable to use 0.75 parts by weight to 1.25 parts by weight of roots of Araliaceae plants with respect to 2 parts by weight of basidiomycete. Furthermore, 1 part by weight of roots of Araliaceae plants is used for 2 parts by weight of basidiomycetes. Specifically, it is preferable that the basidiomycetes are Ganoderma lucidum and Pleurotus cornucopiae, 1 part by weight of Pleurotus cornucopiae and 0.5 to 2 parts by weight of roots of Araliaceae plants per 1 part by weight of Ganoderma lucidum. The root of Araliaceae plant is more preferably 0.75 parts by weight to 1.25 parts by weight.
By weight, more preferably 1 part by weight. In addition, 5 parts by weight of Kawaratake to 10 parts by weight of Ganoderma lucidum
It is also preferable to use 10 parts by weight and 3 parts by weight to 10 parts by weight of roots of Araliaceae plants.

In any of the above-mentioned formulations,
As basidiomycetes, it is preferable to use only Ganoderma lucidum and Pleurotus cornucopiae (both fruiting bodies). Further, preferably, ginseng and / or ginseng ginseng is used as a plant of the family Araliaceae. Particularly preferably, only Chixetuni ginseng is used.

The composition of the present invention may contain only the basidiomycete extract component and the Araliaceae root extract component, but it does not prevent containing other active ingredients. Other active ingredients may be included in the composition of the present invention as long as they do not interfere with the synergistic action of the above-mentioned two kinds of extraction ingredients.

The active ingredient contained in the composition of the present invention has an effect of lowering total cholesterol in blood of mammals including humans. Therefore, the present composition can be used as a therapeutic drug or prophylactic drug against hyperlipidemia in mammals including humans. Here, hyperlipidemia includes the case where the total blood cholesterol level is 220 mg / dl or more and the LDL cholesterol level is 140 mg / dl or more, or both. It also includes the case where blood triglyceride is 150 mg / dl or more. In particular, the composition of the present invention provides a high LD in humans relative to HDL cholesterol.
By lowering L cholesterol, a total cholesterol lowering effect is exerted. Similarly, in humans,
It also has the effect of increasing HDL cholesterol and increasing HDL cholesterol. In addition, in humans,
It has a neutral fat lowering action represented by the blood triglyceride concentration.

In particular, in humans, the total cholesterol lowering action, LDL cholesterol lowering action, HDL cholesterol increasing action and the like have normal blood glucose levels (typically, fasting blood glucose levels are 120 mg / dl or less) to the boundary region (for example, , Fasting blood glucose level exceeds 120mg / dl, 140mg
/ Dl)) and the total amount of cholesterol is effectively exhibited in patients with normal to hyperlipidemia. For these patients, an effect of lowering the amount of triglyceride in blood has also been observed. Further, the total cholesterol lowering action, LDL cholesterol lowering action, and HDL cholesterol increasing action in humans include diabetic patients (both insulin-dependent diabetes and non-insulin-dependent diabetes mellitus) having a fasting blood glucose level of 140 mg / dl or more. , Non-insulin-dependent diabetes mellitus). Among them, total cholesterol lowering effect and L
The DL cholesterol lowering effect was remarkable. And
The blood glucose level itself is significantly reduced, and in addition, blood c-
It also had a peptide lowering effect. That is, the composition of the present invention also has an insulin-like action.

From the above, the composition of the present invention effectively acts on hyperlipidemia as a complication in diabetes, especially in non-insulin-dependent diabetic patients, and lowers total cholesterol and / or LDL cholesterol. be able to. Therefore, the composition of the present invention can be used as a therapeutic drug for hyperlipidemia as a complication in diabetes. Further, it can be used as a drug for treating or preventing hyperlipidemia in humans having normal blood glucose levels or borderline regions. The composition of the present invention obviously has a blood glucose level lowering action and / or a c-peptide lowering action, and can be used as a therapeutic or prophylactic drug for diabetes per se.

The composition of the present invention can be used in combination with the administration of another drug for treating diabetes to non-insulin-dependent diabetic patients. That is, it is clear that the present composition exerts a total cholesterol lowering action and an LDL cholesterol lowering action even when used in combination with other therapeutic agents for diabetes. The present composition hardly causes side effects due to administration of the composition itself, and can also reduce side effects due to other therapeutic agents for diabetes due to the immune activating effect and the like.

Particularly, the effects of lowering total cholesterol and LDL cholesterol are remarkable in the composition containing the root of Chixetuni ginseng as an active ingredient as compared with the roots of other Araliaceae plants. Therefore, when it is used as a therapeutic agent or a preventive agent for hyperlipidemia, it is preferable to use thixet carrot (preferably only thixet carrot) as the root of the Araliaceae plant.

The composition of the present invention has no side effects or only minor side effects. That is, which is a side effect generally observed when an antihyperlipidemic agent or a therapeutic agent for diabetes is administered, numbness of limbs, weakness of limbs, body weakness, muscle pain, swelling, and decrease in urine volume, Fever, cough, constipation, abdominal pain, chest pain, easy to get tired,
No nosebleeds, pale complexion, loss of appetite, headache, etc. were found.
On the contrary, after the start of administration, improvement of headache, recovery of visual acuity, reduction of stress, comfortable sleep, elimination of numbness of limbs, feeling of physical strength, relief of physical pain, less tiredness, complexion, appetite enhancement A phenomenon such as, is observed.

The active ingredient of the present invention is mixed with a pharmaceutically acceptable carrier or additive and used as a composition in a form suitable for administration. The form of the composition is not particularly limited, but a solution, syrup, suspension, powder, granule, tablet, pill, capsule, emulsion, troche, chewable suppository, eye drop, injection, aerosol. , An elixir and the like. It is also preferable to add water at the time of use to prepare a solid (powder) agent capable of recovering the liquid material.

The composition of the present invention can be administered orally or parenterally. It is preferably administered orally. In the administration, general doses for oral administration are shown below. The dose is appropriately set depending on the symptoms, the physical strength of the individual, and the like. The general dose (ordinary dose) is, for example, 5 g to 30 g / total as the total weight of the basidiomycete raw material weight and the dry root weight of roots of Araliaceae plants (preferably roots such as Chixetuni ginseng) used as an extraction raw material. Day / patient (weigh 60 kg; the same applies hereinafter). More preferably, it is 10 to 20 g / day / patient. Particularly, the basidiomycete raw material is preferably 4 g to 25 g / day / patient, more preferably 8.3.
g to 17 g / day / patient. The raw material of the roots of Araliaceae plants is preferably 0.8 g to 5 g / day / patient, more preferably 1.7 g to 3.3 g / day / patient.

For example, in the case of single administration of the water extract which is a typical example of the above-mentioned two kinds of simultaneous extraction, the dose is preferably 400 ml to 500 / day / patient, and for example, it is preferable to administer it twice a day. In addition, in the case of the ethanol / water mixed liquid extract alone administration, which is a typical example of the above-mentioned two kinds of simultaneous extraction,
The dose is preferably ml / day / patient and is preferably orally administered twice a day. Further, in the combined administration of the water extract of the typical example and the ethanol / water mixture extract, the water extract is 180 to 220 ml (preferably 200 ml).
/ Day / patient and ethanol / water mixture extract 45-55
It is preferable to make it into ml (preferably 50 ml) / day / patient, and it is preferable to orally administer these twice a day.

Since the composition of the present invention has extremely low toxicity and does not cause serious side effects, it can be safely administered even at a high dose depending on the symptoms.

[0050]

INDUSTRIAL APPLICABILITY According to the present invention, there is provided an antihyperlipidemic composition which has a preferable cholesterol-lowering effect and has no or sufficiently reduced side effects. At the same time, a composition for diabetes is provided. Further provided is an antihyperlipidemic composition for diabetic patients.

[0051]

EXAMPLES Example 1 The present invention will be described below with reference to specific examples, but the present invention should not be construed as being limited to these examples. (Preparation of composition) 1. Water-extracting composition 10 g of dried fruiting body of natural Ganoderma lucidum, dried fruiting body 5 of Kawaratake, crushed into pieces of about 0.5 to 2 mm square
g, and 800 g of hot water was added to the raw material mixture of 3 g of dried root of Chixetuni ginseng, and the mixture was decocted so that the remaining amount of the extract was 500 ml in about 30 minutes. The temperature of the extract during brewing was approximately 90-95 ° C. This extract was directly used as a composition for oral administration. 2. Alcohol / water mixed liquid extract composition To a raw material mixture of 100 g of dried fruit body of natural Ganoderma lucidum, 50 g of dried fruit body of Kawaratake mushroom, and 30 g of dried root of Chixetuni ginseng crushed into pieces of about 0.5 to 2 mm square Add 1000 ml of 35v / v %% ethanol solution
This liquid was maintained at about 70 ° C. and decocted for about 30 hours.
The temperature of the extract during brewing was approximately 70 ° C. After 30 hours, hot water was added so that the total amount became 1000 ml. The final alcohol concentration is about 20.
It was v / v%. This extract was directly used as a composition for oral administration.

(Example 2) (Clinical Administration Example 1) The two compositions obtained in Example 1 were used in combination and the diet therapy was continued for 1 month prior to the present administration, and the diet therapy period was continued. It was orally administered to 5 patients who had not been administered other drugs including a therapeutic agent for diabetes. In addition, as shown in Table 1, the patients are high-risk patients with non-insulin-dependent diabetes mellitus whose blood glucose level before administration of the present composition is in the normal to borderline region. For administration, these compositions were drunk as they were. The dosage is
200ml / day of water extract composition (100m each in morning and evening
1) and 50 ml / day of an alcohol / water mixed liquid extract composition (25 ml each in the morning and evening). The administration was continued for 28 consecutive days, and the diet was continued during this period.
Patients also had plant allergies, neuropathy, gastroenteritis,
He had neither liver dysfunction nor renal dysfunction.

Blood was collected from these patients before the start of the administration and after the end of the administration period, and the results of measuring the concentrations of total cholesterol, LDL cholesterol, HDL cholesterol, triglyceride (TG), glucose, and C-peptide are shown. Shown in 1. The total cholesterol, LDL, HDL and triglyceride were measured by the enzyme method, and the c-peptide was measured by the RIA method.

[0054]

[Table 1]

As shown in Table 1, total cholesterol, L
DL cholesterol showed the same tendency or a slight decrease after the end of the administration period. In contrast, HDL cholesterol tended to increase slightly. Triglyceride was decreased in all patients. When it comes to cholesterol, overall cholesterol and LDL cholesterol are lowered,
It was found that L cholesterol tends to increase and TG also tends to decrease. On the other hand, the blood glucose level and C-peptide were almost the same level before and after administration. From the above, it was found that the present composition can be used for preventing or treating hyperlipidemia.
Further, it was found that it can be used for prevention or treatment of hyperlipidemia in patients with normal to borderline blood glucose levels. In particular, it was found to be effective for high-risk patients with non-insulin dependent diabetes.

(Example 3) (Clinical administration example 2) The two compositions obtained in Example 1 were used in combination and the diet therapy was continued for 1 month before the administration of the present case, and the diet therapy period was Oral administration was carried out to 3 patients who had not been administered other drugs including a therapeutic agent for diabetes. As shown in Table 2, the patients had high blood glucose levels before administration of the present composition, and all were insulin-independent diabetes patients. For administration, these compositions were drunk as they were. The usage and dose were the same as in Example 2. The administration was continued for 28 consecutive days, and the diet was continued during this period. The patients had neither plant allergy, neuropathy, gastroenteritis, liver dysfunction nor renal dysfunction.

Blood was collected from these patients before the start of administration and after the end of the administration period in the same manner as in Example 2 to obtain total cholesterol, LDL cholesterol and HDL.
The results of measuring the concentrations of cholesterol, triglyceride, glucose, and C-peptide are shown in Table 2.

[0058]

[Table 2]

As shown in Table 2, the total cholesterol was significantly decreased after the administration period (76 to 99).
%, Average 88%). For LDL cholesterol,
Significantly reduced (62-94%, average 79%). In contrast, HDL cholesterol was increased overall (94-115%, average 106%). In terms of cholesterol, total cholesterol and LD as a whole
It was found that L-cholesterol tends to be significantly lowered and HDL-cholesterol tends to increase. On the other hand, blood glucose levels decreased in all patients (76 to 91).
%, 83% on average), showing a remarkable blood glucose lowering effect.
Regarding c-peptide, it was significantly reduced in 2 persons (7
1%, 78%), but one person increased (121%)
However, as a whole, it decreased (86%). That is,
High efficacy was shown also in the blood glucose level lowering action or the c-peptide lowering action. From the above, it was found that the present composition can be used for preventing or treating hyperlipidemia. Further, it was found that the present composition can be used for the prevention or treatment of hyperlipidemia in diabetic patients with high blood glucose level. At the same time, it was found that it can be used for prevention or treatment of diabetes.

Example 4 (Clinical Administration Example 3) The two compositions obtained in Example 1 were used in combination, and the diet therapy was continued for 1 month prior to the administration of this case, and the diet therapy period was Among them, the antidiabetic agent alone was orally administered to two patients under treatment. As shown in Table 3, the patients had high blood glucose levels before administration of the composition, and all were insulin-independent diabetes patients. In addition, the antidiabetic drug that patients had been administered was su
lfonureeds, the dose was 3 mg / day, and the administration was once a day. The usage and dose of this composition were the same as in Example 2. The administration was continued for 28 consecutive days, and during this period, the diet and the antidiabetic agent were continuously administered at the same dosage as before the administration. The patients had neither plant allergy, neuropathy, gastroenteritis, liver dysfunction nor renal dysfunction.

Blood was collected from these patients before the start of the administration and after the end of the administration period in the same manner as in Example 2 to obtain total cholesterol, LDL cholesterol and HDL.
The results of measuring the concentrations of cholesterol, triglyceride, glucose, and C-peptide are shown in Table 3.

[0062]

[Table 3]

As shown in Table 3, total cholesterol decreased after the administration period (96%, 89%).
%, Average 92%). For LDL cholesterol,
Remarkably decreased (94%, 74%, average 83%). On the other hand, the blood glucose level was decreased in all patients (86%, 84%, average 85%). Regarding c-peptide, although it was significantly decreased (68%) in one person, it was increased (107%) in one person, but it was decreased (87%) as a whole. From the above, even when the antidiabetic agent is used in combination, the present composition significantly exerts a total cholesterol lowering action and an LDL cholesterol lowering action, which is preferable for use in combination with the antidiabetic agent. It was found to be a prophylactic or therapeutic agent.

[0064]

INDUSTRIAL APPLICABILITY According to the present invention, a composition for preventing or treating hyperlipidemia having a preferable cholesterol-lowering effect is provided, and a composition for preventing or treating diabetes which is excellent in a blood glucose-lowering effect is also provided. It Also provided is a composition for preventing or treating hyperlipidemia in diabetic patients.

Claims (9)

[Claims] 1. An antihyperlipidemic composition comprising, as active ingredients, one or more kinds of basidiomycetes belonging to the basidiomycetes Sarcobidae and roots of plants belonging to the family Araliaceae. 2. The composition according to claim 1, wherein the one or more basidiomycetes is Ganoderma lucidum and / or Kawaratake. 3. The plant of the family Araliaceae is ginseng,
It is 1 type (s) or 2 or more types selected from the group which consists of Chixetuni ginseng and Denshi ginseng.
Or the composition according to 2. 4. The composition according to claim 1, which has a raw material composition of 15 to 20 parts by weight of the roots of Araliaceae plants with respect to 100 parts by weight of the basidiomycete. 5. The composition according to claim 1, wherein the basidiomycetes are of two types, Ganoderma lucidum and Pleurotus cornucopiae, and the Araliaceae plant is Chixetuni ginseng. 6. 9 to 11 parts by weight of Ganoderma lucidum, 4.5 to 5.5 parts by weight of Ganoderma lucidum, 2.7 to 3.
The composition of claim 5 having a raw material composition of 3 parts by weight. 7. A blood glucose level lowering action as well.
7. The composition according to any one of to 6. 8. A composition for treating or preventing diabetes, which comprises, as active ingredients, one or more kinds of basidiomycetes belonging to the family Basidiomycetes Asteraceae and roots of plants belonging to the family Araliaceae. 9. An antihyperlipidemic composition for a diabetic patient, which comprises, as active ingredients, one or more kinds of basidiomycetes belonging to the family Basidiomycetes Asteraceae and roots of plants belonging to the family Araliaceae.